BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1760723 · Received July 15, 2010

    Report

    Report Number
    2953200-2010-01327
    Event Type
    Injury
    Date Received
    July 15, 2010
    Date of Event
    June 19, 2010
    Report Date
    June 19, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ARTERIAL AND VENOUS OCCLUSION. SEVERE THROMBUS IN THE AORTIC NECK. CONCLUSION: SEVERE THROMBUS IN THE AORTIC NECK.

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS INSERTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED, OTHER THAN THAT THE AORTIC NECK HAD SEVERE THROMBOSIS. IT WAS REPORTED THAT THE TALENT BIFURCATED STENT GRAFT WAS IMPLANTED WITHOUT ISSUES; HOWEVER, THE PATIENT PRESENTED WITH BACK PAIN 5 DAYS POST-IMPLANT, AND THE CT DEMONSTRATED THAT THE RIGHT RENAL ARTERY WAS OCCLUDED. THE APEX OF THE STENT GRAFT WAS ACROSS THE RENAL ARTERY, AND IT IS POSSIBLE THAT SOME THROMBOSIS IN THE AORTA MAY HAVE BEEN PUSHED INTO THE RENAL ARTERY. THE PHYSICIAN ELECTED TO INTERVENE BY ATTEMPTING TO INSERT A CATHETER INTO THE RENAL ARTERY; HOWEVER, AS THE ARTERY WAS TOO OCCLUDED, IT WAS DECIDED TO ABORT THE INTERVENTION. THE PATIENT WAS NOT TREATED AND WAS DISCHARGED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00407400

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention